• Ascent Healthcare Solutions (Phoenix) said that the FDA has increased the number of times that Ascent can reprocess the AcuNav ultrasound catheter from two to up to four times. Covered devices include the 10 Fr and 8 Fr models. The catheters provide electrophysiologists and interventional cardiologists with high-quality images and blood flow information throughout the entire heart for the diagnosis of certain cardiac arrhythmias. Ascent Healthcare Solutions is a reprocessor of medical devices for hospitals and healthcare providers throughout North America.

• Eclipsys (Boca Raton, Florida) reported that PowerBANK Enterprise Edition has received FDA 510K clearance. PowerBANK is Eclipsys' solution for automating the functions of a hospital's blood bank and is a component of Eclipsys sunrise laboratory. PowerBANK automates the processes from receipt of blood products to monitoring blood products and patient results as well as issue and transfusion documentation. It provides functionality for complete product inventory management and includes reports capabilities on receipt, release and results of blood products. Eclipsys makes integrated information software, clinical content and provides professional services that help healthcare organizations.

• WaveLight (Sterling, Virginia) reported FDA approval of its wavefront-guided and mixed astigmatism indications for the Allegretto Wave Eye-Q system. The Eye-Q wavefront-guided LASIK procedure was approved for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent of myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane. The procedure may be performed on patients who are 18 years of age or older with documentation of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. The procedure may also be performed with a custom offset of -3.00 to +1.00 D for sphere and -3.00 to 0.00 D for cylinder. The Eye-Q was approved for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane in patients who are 21 years of age or older with documentation of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. WaveLight makes products for ophthalmology and specializes in vision optics.

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